(25 days)
Not Found
Not Found
No
The summary describes a mechanical device (washers, bolt, nut) for anchoring soft tissue to bone and contains no mention of AI, ML, image processing, or data-driven performance metrics.
No
The device is used for anchoring soft tissue to bone, which is a supportive mechanical function rather than a therapeutic one that treats or heals a disease or condition.
No
Explanation: The device is described as Soft Tissue Anchoring Washers intended for anchoring soft tissue to bone. Its stated use is mechanical fixation, not diagnosis. The provided information does not mention any diagnostic capabilities such as detecting, identifying, or monitoring medical conditions.
No
The device description clearly indicates physical components ("washers", "bolt nut") used for anchoring soft tissue to bone, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for anchoring soft tissue to bone." This describes a surgical or mechanical function within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as "Soft Tissue Anchoring Washers [washers], [washer, bolt nut]". This further reinforces its nature as a physical implant or surgical component.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
IVDs are used to examine specimens from the human body to provide information for diagnostic purposes. This device's function is purely mechanical and structural within the body.
N/A
Intended Use / Indications for Use
The Soft Tissue Anchoring Washers [washers], [washer, bolt nut] Indications For Use: are to be used for anchoring soft tissue to bone.
Product codes
KGS; MBI
Device Description
Soft Tissue Anchoring Washers [washers], [washer, bolt nut]
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4930 Suture retention device.
(a)
Identification. A suture retention device is a device, such as a retention bridge, a surgical button, or a suture bolster, intended to aid wound healing by distributing suture tension over a larger area in the patient.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Accu-Speed, Inc. Robert W. Secovich President P. O. Box 1008 65 Gay Road Groton, Massachusetts 01450
JAN 2 8 2003
Re: K030031
Trade/Device Name: Soft Tissue Anchoring Washers Regulation Number: 878.4930 Regulation Name: Suture retention device Regulatory Class: Class II Product Code: KGS; MBI Dated: December 24, 2002 Received: January 3, 2003
Dear Mr. Secovich:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally
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Page 2 - Mr. Robert W. Secovich
marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark A Millman
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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VII. INDICATIONS FOR USE STATEMENT
510(k:) Number:
Soft Tissue Anchoring Washers [washers], [washer, bolt nut] Device Name:
The Soft Tissue Anchoring Washers [washers], [washer, bolt nut] Indications For Use: are to be used for anchoring soft tissue to bone.
Mark A. Wilkerson
Jivision Sign-Off) Division of General, Restorative and Neurological Devices
Number K03003/